MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333334
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal: it was reported that patients tha got infected.Revision surgery and femur and acetabulum were debrided and later treated with a girdlestone procedure.

• Brand Name: REF XLPE 32 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9988930
• Report Number: 1020279-2020-01353
• Device Sequence Number: 3676769
• Product Code: JDI
• UDI-Device Identifier: 03596010455673
• UDI-Public: 03596010455673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2016
• Device Model Number: 71333334
• Device Catalogue Number: 71333334
• Device Lot Number: 06KM12120
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 10/03/2021
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1